This invention relates to chewing gum compositions containing active ingredients. More particularly, this invention relates to producing chewing gums that contain compounds for treating ulcers and halitosis.
Chewing gum compositions, typically, include a water soluble bulk portion, a water insoluble chewing gum base portion and water insoluble flavoring agents. Also, chewing gum compositions can be formulated to provide the delivery of active agents. These active agents may be a variety of breath fresheners, or medicaments, such as laxatives, aspirin or nicotine. Delivering these medicaments through a chewing gum vehicle is desirable for people who have difficulty swallowing pills. Also, the bad taste of some of the agents may be disguised by stronger flavoring agents in the chewing gum, which may make gum a suitable vehicle for delivery of certain medicines. Moreover, some medicines may be absorbed directly into the bloodstream through the tissue lining the mouth, making the medicine more readily available than if absorbed through the gastrointestinal walls. Accordingly, many people can benefit from new discoveries of how to effectively deliver active ingredients through a chewing gum formulation.
Unfortunately, many active ingredients are not suitable for administration through a chewing gum for a variety of reasons. A chewing gum cannot be effective if it has unpleasant medicinal taste, causes discoloration in the user's mouth, or the active ingredient causes poor chewing characteristics. A chewing gum cannot be effective if the active ingredient is not readily released from the gum, and thus, not delivered either into the mouth or the stomach where it can be absorbed or act topically. For this reason, many active ingredients may be effectively delivered by chewable tablets, or swallowable tablets, but not by chewing gum.
Recent discoveries have associated bacterial infection in the causation of peptic ulcer disease. The bacterium found to be associated with peptic ulcers has been identified as Helicobacter pylori. Excessive gastric acidity and mental stress are no longer thought to be the major pathophysiological reasons for the occurrence of peptic ulcers. Thus, questions regarding the previously established paradigms of and approaches for ulcer treatment and healing processes have been raised.
Previously, ulcers were treated by suppressing secretion of acid in the stomach. H2-receptor blockers, such as cimetidine (Tagamet.RTM.) and Ranitidine (Zantac.RTM.), suppress acid secretion and have been used to treat and heal duodenal ulcers. However, these H2-receptor blockers do not eliminate the Helicobacter pylori bacteria ("H. pylori"). These drugs do not reverse the tendency for ulcers to form.
For many years bismuth compounds have been used in swallowable tablet form and liquid form for treating ulcers. The therapeutic efficacy of bismuth compounds such as colloidal bismuth subcitrate, CBS, (also known as tripotassium dicitrato bismuthate), in healing duodenal ulcers and lowering relapse rates is attributed to its specific anti-bacterial activity against H. pylori. However, using bismuth compounds alone, H. pylori eradication rates of about 10 to 40% has been reported. Also, patients would suffer a relapse of ulcers after discontinuing taking the bismuth compounds.
Even though, as a single agent, CBS is significantly more effective in eradicating H. pylori than many other antibiotics, multiple therapies of bismuth compounds combined with other antibiotics have been reported to result in more than a 95% eradication rate for H. pylori and reduced ulcer relapse rate to less than 10% during a twelve-month follow-up period. For example, one such common triple therapy, comprised of CBS, amoxicillin and metronidazole, has been reported to have a high rate of effectiveness. However, it would be desirable to achieve such effectiveness in eradicating H. pylori with simple single agent therapies. No such single agent heretofore has been shown to be effective.